G7® 110018822Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biomet Orthopedics manual surgical instrument is a positioning guide rod used during hip replacement surgery. Most of the 34 reports describe the rod breaking or snapping while being tightened onto the impactor or cup implant, sometimes leaving the guide too loose to use, and occasionally making it hard to insert. No deaths or injuries are reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00887868468742), received between Jan 13, 2023 and Mar 31, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Fracture” (30 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture30
- Difficult to Insert2
- Naturally Worn2
- Material Twisted/Bent1
- Mechanical Problem1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742841 ↗MalfunctionMar 9, 2026Fracture
IT WAS REPORTED THAT WHILE TIGHTENING THE ALIGNMENT GUIDE ROD ONTO THE IMPACTOR WITH THEIR FINGERS, THE BOTTOM 4-5 MM BROKE OFF. THE PIECE WAS RETRIEVED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24544929 ↗MalfunctionMar 5, 2026Fracture
IT WAS REPORTED THAT WHILE SCREWING THE ROD ONTO THE HANDLE, THE DISTAL COMPONENT BROKE, MAKING THE GUIDE UNSTABLE. ALL PIECES RETRIEVED AND NOTHING FELL IN PATIENT. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24524514 ↗MalfunctionJan 27, 2026Fracture
IT WAS REPORTED THAT WHEN SCREWING THE GUIDE ROD INTO THE IMPACTOR ON THE BACK TABLE, THE GUIDE ROD BROKE LEADING TO REMAINING COMPONENTS FITTING LOOSELY. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192288 ↗MalfunctionJan 22, 2026Fracture
IT WAS REPORTED THAT WHILE SCREWING THE GUIDE ROD ONTO THE IMPACTOR, THE DISTAL PART OF THE ROD BROKE, RENDERING THE GUIDE TOO LOOSE TO USE AS INTENDED. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24143876 ↗MalfunctionJan 14, 2026Fracture
IT WAS REPORTED THAT THE POSITIONING GUIDE ROD TIP BROKE WHILE BEING TIGHTENED ONTO THE CUP IMPLANT. ANOTHER GUIDE ROD WAS OPENED TO COMPLETE THE CASE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24069142 ↗MalfunctionDec 17, 2025Fracture; Fracture
IT WAS REPORTED THAT PRIOR TO THE CASE, IT WAS NOTICED THAT THE DISTAL PORTION OF THE POSITIONING GUIDE ROD WAS BROKEN. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829282 ↗MalfunctionDec 15, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23811888 ↗MalfunctionDec 15, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802078 ↗MalfunctionNov 18, 2025Fracture; Fracture
IT WAS REPORTED THAT GUIDE ROD WAS TIGHTENED DOWN AND BROKE. NO PATIENT HARM OR IMPACT. NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23585201 ↗MalfunctionNov 18, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE ATTEMPTING TO SECURE THE ALIGNMENT GUIDE TO THE SHELL INSERTER, THE TIP OF THE POSITIONING GUIDE ROD BROKE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23581760 ↗MalfunctionOct 7, 2025Fracture; Fracture
NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23232586 ↗MalfunctionAug 20, 2025Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22849480 ↗MalfunctionJul 15, 2025Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22506010 ↗MalfunctionJan 17, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE DISTAL PART OF THE OF THE POSITIONING GUIDE ROD WOULD NOT CONNECT WELL WITH THE IMPACTOR AS INTENDED. THE DEVICE KEPT FALLING TO THE SIDE INSTEAD OF MAINTAINING CONTACT WITH THE IMPACTOR. THERE WAS NO HARM OR HEALTH CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179989 ↗MalfunctionJan 15, 2025Fracture; Fracture
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21159803 ↗MalfunctionDec 11, 2024Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20901448 ↗MalfunctionDec 4, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE THREADS ON THE VERSION GUIDE ROD ARE WARPED AND BENT. THERE WAS NO PATIENT INVOLVEMENT, AND IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20844021 ↗MalfunctionOct 15, 2024Fracture; Fracture
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20454110 ↗MalfunctionAug 6, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING DISASSEMBLY OF THE CUP INSERTER, IT BROKE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917419 ↗MalfunctionJul 17, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19759941 ↗MalfunctionJul 16, 2024Fracture; Fracture
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19749021 ↗MalfunctionJul 15, 2024Naturally Worn; Positioning Problem; Naturally Worn; Positioning Problem
IT WAS REPORTED THAT THE POSITIONING GUIDE RODS HAVE BEEN AFFECTED BY THE SCREWING SO THE METAL END IS WORN AND DOES NOT CONTACT WELL WITH THE IMPACTOR AS INTENDED. THE GUIDE RODS KEEP FALLING ON THE SIDE INSTEAD OF STAYING CONNECTED TO THE IMPACTOR. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19744223 ↗MalfunctionJun 20, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE HOLDING PIN FOR ACETABULAR CUP ALIGNMENT TOOL IS CROSS THREADED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19575666 ↗MalfunctionApr 15, 2024Fracture; Difficult to Insert; Naturally Worn; Fracture; Difficult to Insert; Naturally Worn
THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19107046 ↗
Other Orthopedic manual surgical instrument devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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